Regulamentação sanitária de medicamentos

Registro completo de metadados
MetadadosDescriçãoIdioma
Autor(es): dc.contributorUniversidade Estadual Paulista (UNESP)-
Autor(es): dc.creatorMastroianni, P. C.-
Autor(es): dc.creatorLucchetta, R. C.-
Data de aceite: dc.date.accessioned2025-08-21T21:41:06Z-
Data de disponibilização: dc.date.available2025-08-21T21:41:06Z-
Data de envio: dc.date.issued2022-04-28-
Data de envio: dc.date.issued2022-04-28-
Data de envio: dc.date.issued2011-06-28-
Fonte completa do material: dc.identifierhttp://hdl.handle.net/11449/226398-
Fonte: dc.identifier.urihttp://educapes.capes.gov.br/handle/11449/226398-
Descrição: dc.descriptionThe health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and 'similar' brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program.-
Descrição: dc.descriptionDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas da UNESP, Rodovia Araraquara - Jaú, km 1, Araraquara, SP, CEP.14801-902-
Descrição: dc.descriptionDepartamento de Fármacos e Medicamentos Faculdade de Ciências Farmacêuticas da UNESP, Rodovia Araraquara - Jaú, km 1, Araraquara, SP, CEP.14801-902-
Formato: dc.format127-132-
Idioma: dc.languageen-
Idioma: dc.languagept_BR-
Relação: dc.relationRevista de Ciencias Farmaceuticas Basica e Aplicada-
???dc.source???: dc.sourceScopus-
Palavras-chave: dc.subjectGeneric Drugs-
Palavras-chave: dc.subjectModification of Product Registration-
Palavras-chave: dc.subjectOriginal Brand-name Drugs-
Palavras-chave: dc.subjectProduct Registration-
Palavras-chave: dc.subjectSimilar Drugs-
Título: dc.titleRegulamentação sanitária de medicamentos-
Título: dc.titleHealth regulations for drugs-
Tipo de arquivo: dc.typelivro digital-
Aparece nas coleções:Repositório Institucional - Unesp

Não existem arquivos associados a este item.